Three-Month Atypical Antipsychotic Delays Schizophrenia Relapse

A long-acting atypical antipsychotic that is given every three months could soon receive FDA approval after Janssen R&D announced that a Phase III study of paliperidone palmitate significantly delayed time to relapse compared to placebo.

The randomized, double-blind, placebo-controlled, relapse prevention study randomized patients to either the three-month paliperidone palmitate (Invega Sustenna) treatment group (n=160) or to the placebo group (n=145).

All enrolled patients met the DSM-IV diagnosis of schizophrenia and had a Positive and Negative Syndrome Scale (PANSS) total score of less than 120 at screening and baseline. Prior to randomization, individuals were first stabilized with paliperidone palmitate one-month formulation during a 17-week, open-label transition period.

Patients who met criteria for clinical stability then received a single three-month paliperidone palmitate injection during a 12-week, open-label maintenance phase. Stable patients were then randomized to treatment with either three-month paliperidone palmitate or placebo. Patients remained in the double-blind phase (n=305) until they relapsed, withdrew from the study, or the study terminated.